Rosuvastatin in Visceral Adiposity (RIVIERA)

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The purpose of this study is to investigate whether 6 months treatment with the cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged men.

Condition or disease

Intervention/treatment

Phase

Abdominal Obesity

Drug: RosuvastatinDrug: Placebo for rosuvastatin

Phase 3

Detailed Description:

The accumulation of intra-abdominal fat has been suggested to be of primary importance in the development of the metabolic syndrome and associated metabolic disturbances and it has been hypothesized that a selective reduction of visceral fat tissue would improve the symptoms of the metabolic syndrome. Treatment with statins decrease levels of LDL-cholesterol and reduce coronary artery disease (CAD) events. Although it is widely accepted that the majority of benefit obtained with statins is a direct result of their lipid-lowering properties, they also demonstrate additional cholesterol-independent or pleiotropic effects. The results of experimental studies have now shown that statins decrease fat mass in the visceral region in an animal model. In the present study, we will investigate whether statins can decrease visceral obesity in humans.

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Ages Eligible for Study:

40 Years to 65 Years (Adult)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male patients between 40 and 65 years of age.

Abdominal obesity

Dyslipidemia

Written informed consent.

Exclusion Criteria:

Uncontrolled hypertension

Diabetes mellitus

Severe liver disease

Severely reduced renal function

Uncontrolled endocrine disorders

History of or ongoing malignant disease

Patients with known myopathic disease

Recent alcohol or drug abuse

Weight loss or weight gain during the three months prior to screening.

Ongoing treatment with statins

Ongoing treatment with calcineurin-inhibitors

Ongoing treatment with anti-inflammatory drugs

Received an investigational drug within 30 days prior to screening.

Strong clinical indication for statin treatment

In the Principal Investigator's opinion, the patient has other clinically significant cardiac, oncologic, neurologic or psychiatric disease that could be adversely affected by Study participation.

For any reason the patient is considered by the Principal Investigator to be an unsuitable candidate to participate in the Study.